Application 011722

Type: NDA
Sponsor: NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	TENUATE	DIETHYLPROPION HYDROCHLORIDE	TABLET;ORAL	25MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011722-002	TENUATE	DIETHYLPROPION HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011722-002	TENUATE	25MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011722-002	TENUATE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011722-002	TENUATE	25MG	TABLET / ORAL		RLD, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N011722-002	AA	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	A-S Medication Solutions	04f1a804-00f1-48f5-acfa-0ed1a8544784	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ad0c3dc9-ae13-4853-bc8c-a66e2a69cc10	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0d213a24-ebbf-41df-8f32-de44a572829e	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5777eed8-c63d-49c4-9dd1-9d087906c368	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	OMNIVIUM PHARMACEUTICALS LLC.	cd4f2b19-8752-4fed-81f3-d3074ade613c	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	Martek Pharmacal Co.	130511dc-8f01-02ca-e063-6394a90a671b	2025-07-21	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	335fb85d-8b1f-e648-e063-6294a90aa158	2025-04-22	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	335265e0-1d5d-31fb-e063-6394a90a2e75	2025-04-21	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	Calvin Scott & Co., Inc.	fa48ad75-4fc8-4355-a19d-cd1b9d87f553	2025-02-27	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Calvin Scott & Co., Inc.	d6cde8cc-26ae-4087-8eac-b11192749cc5	2025-02-25	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe7e5022-8b58-aa4f-e053-6294a90af65e	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	A-S Medication Solutions	7f4eca5b-f850-44fc-88b4-4d9bcdf2ba44	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Chartwell RX, LLC.	b8984c2d-244e-4c56-be3e-c402dc679b1f	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Chartwell RX, LLC.	fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	54655904-7ce2-49d5-9acf-81ad9680d215	2024-10-02	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fb8e2f1b-24ef-4e1d-a493-4c3b3de05b26	2024-08-07	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	89306917-a65b-40d4-9c51-d59ac0ad2017	2024-08-07	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	KVK-TECH, INC	3ecb7bd7-e04c-47fe-859a-8ba8a54f9aff	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Lannett Company, Inc.	dab53f4f-68d4-4477-a2b6-ad44a956332b	2022-07-27	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Proficient Rx LP	2a2fbc1b-6430-485b-b581-10fbfca0af88	2020-10-01	Warnings, Adverse reactions	Name fallback generic name: DIETHYLPROPION HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-0783	Diethylpropion HCl Immediate-Release	Diethylpropion hydrochloride	Actavis Pharma, Inc.	NDA	Current
10544-598	Diethylpropion HCl Controlled-Release	Diethylpropion hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
12634-530	Diethylpropion Hydrochloride	Diethylpropion hydrochloride	Apotheca Inc.	NDA	Current
21695-876	Diethylpropion HCl Controlled-Release	Diethylpropion hydrochloride	Rebel Distributors Corp	NDA	Current
50090-0326	Diethylpropion HCl Immediate-Release	Diethylpropion hydrochloride	A-S Medication Solutions	NDA	Current
63629-4010	Diethylpropion HCl Immediate-Release	Diethylpropion hydrochloride	Bryant Ranch Prepack	NDA	Current
66267-076	Diethylpropion HCl Immediate-Release	Diethylpropion hydrochloride	NuCare Pharmaceuticals, Inc.	NDA	Current
66267-076	Diethylpropion HCl Immediate-Release	Diethylpropion hydrochloride	NuCare Pharmaceuticals, Inc.	NDA	Current
68387-695	Diethylpropion HCl Immediate-Release	Diethylpropion hydrochloride	Keltman Pharmaceuticals Inc.	ANDA	Current
68387-696	Diethylpropion HCl Controlled-Release	Diethylpropion hydrochloride	Keltman Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10776	SUPPL	2004-09-07
284	SUPPL	2004-09-07